Just as everyone has their own fingerprints, individual tumors also have different genetic “fingerprints.” What if cancer treatment could be personalized depending on the specific type of fingerprinting a tumor presents?
This is what Amgen, together with the National Cancer Institute, Genentech, Pfizer, AstraZeneca PLC, and AstraZeneca’s global biologics partner, MedImmune, intend to achieve in the new clinical trial program Lung Master Protocol (Lung-MAP).
With lung cancer being the leading cause of cancer death and the second most common cancer in the U.S, this groundbreaking biomarker-driven, multi-drug, multi-arm Phase2/3 clinical trial can prove of enormous medical relevance.
Each year, about 500 to 1,000 patients with advanced squamous cell lung cancer, a hard-to-treat form of lung cancer, will receive treatments based on their individual cancer profiles. Each patient will be screened for mutations in over 200 cancer-related genes to find which of the five investigational compounds, including Amgen’s rilotumumab (a human monoclonal antibody), will benefit them the most.
The use of such a large-scale biomarker-based clinical trial will surely overcome the inefficiency of current genetic screens to find particular mutations targeted by cancer medicines used in the clinic and will also minimize the number of patients exposed to ineffective therapies.
This innovative study will involve 500 hospitals around the country as well as some private groups, and will come to a cost of about 150$ million, partly funded by the National Cancer Institute and partly funded by foundations, charities and other public-private partnership.
Sean E. Harper, M.D., executive vice president of Research and Development at Amgen stated that this jointly “tour-de-force” can “significantly speed our understanding of targeted approaches for this complex form of lung cancer, while demonstrating how genomic testing can drive the evolution of clinical trial design”. Future plans for similar studies targeting breast and colon cancer are also being developed.
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